INFINITY KAPPA XLT

K042904 · Draeger Medical Systems, Inc. · MHX · Feb 18, 2005 · Cardiovascular

Device Facts

• Record ID: K042904
• Device Name: INFINITY KAPPA XLT
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, I he inimity trapper HD rovingia, temperature, cardiac output, arterial oxygen saturation, pulse non invasite prossure, and 12-Lead ST Segment Analysis. The device produces rate, apped, of beginent if any of the physiological parameters monitored vary beyond preset Imits and timed or alarm recordings will be produced. The device will connect to an R50 millis and thised or thank rocereings with the evice is capable of displaying clinical data received over a hospital information system.

Device Story

Infinity Kappa XLT is a patient monitoring system combining features of Infinity Delta/DeltaXL/Kappa and Infinity Explorer. System components: Vital Signs Engine (signal acquisition), medical-grade display, and power supply. Inputs: physiological signals (ECG, pressure, temperature, SpO2, respiration, EEG via pod, muscle response via NMT pod, gas concentrations via SCIO module). Operation: continuous monitoring of vital signs; visual/audible alarms triggered when parameters exceed preset limits; data recording via R50 recorder; integration with hospital information systems. Used in clinical environments by healthcare professionals to assess patient condition and guide clinical decisions. Benefits: real-time patient status awareness and automated alarm notification.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing in accordance with applicable standards and internal design control procedures.

Technological Characteristics

Modular patient monitoring system. Components: Vital Signs Engine, display, power supply. Connectivity: Infinity Network, RS-232 interface for third-party devices, hospital information system integration. Standards: IEC 60601-1. Software-driven architecture combining monitoring and workstation functionality.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring physiological monitoring. Parameters include heart rate, respiration, invasive/non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, and ST segment analysis. Cardiac output, ST segment, and arrhythmia monitoring are restricted to adult and pediatric populations. Intended for use by healthcare professionals (physicians, nurses, technicians) in clinical settings.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Infinity Explorer (K040945)
• Infinity Delta / DeltaXL / Kappa (K033957)
• Infinity SC 8000 (K012016)

Submission Summary (Full Text)

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K042904

#### 510(k) SUMMARY FEB | 8 2005

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: [phone] Fax: [phone] Contact person for this submission: Penelope H. Greco October 20, 2004 Date submission was prepared:

Trade Name, Common Name and Classification Name:

A. Trade Name: Infinity Kappa XLT

# B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classification Number | Class | Regulation Number |
|----------------------------------------------------------------------|-----------------------|-------|-------------------|
| Monitor, physiological, patient (with arrhythmia detection or alarms | MHX | 2 | 870.1025 |
| System, Network and Communication, Physiological Monitors | MSX | 2 | 870.2300 |
| Computers and Software, Medical | LNX | | |

Predicate Device Identification:

Infinity Explorer (K040945) Infinity Delta / DeltaXL / Kappa (K033957) Infinity SC 8000 (K012016)

Device Description:

The Infinity Kappa XLT is an addition to Draeger's INFINITY patient monitoring system that combines on one platform the patient monitoring features of the Infinity Delta/DeltaXL/Kappa and the Infinity Explorer, Draeger's software-driven critical care workstation.

The Kappa XLT System consists of three basic components:

- The Kappa XLT Vital Signs Engine that acquires all signals ●
- The Kappa XLT Display, a medical grade display unit .
- . The Kappa XLT Power Supply.

Page 1 of 2

### Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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## Intended Use:

The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, I he inimity trapper HD rovingia, temperature, cardiac output, arterial oxygen saturation, pulse non invasite prossure, and 12-Lead ST Segment Analysis. The device produces rate, apped, of beginent if any of the physiological parameters monitored vary beyond preset Imits and timed or alarm recordings will be produced. The device will connect to an R50 millis and thised or thank rocereings with the evice is capable of displaying clinical data received over a hospital information system.

Assessment of non-clinical performance data for equivalence:

The Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices.

Assessment of clinical performance data for equivalence:

Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer.

Biocompatability:

Not applicable

Sterilization:

Not applicable

Standards and Guidance: IEC 60601-1

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Draeger Medical Systems c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923

K042904 Re: Trade Name: Infinity Kappa XLT Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: 74 MHX Dated: January 20, 2005 Received: January 21, 2005

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 eonimered prior to may 2017 11:11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Penelope H. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i touse oc northou that I Dr bristian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderated and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic for at many a morely by so wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will anow yours ough finding of substantial equivalence of your device to a legally prestiated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimma for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use K042904

510(k) Number (if known):_

Device Name: Infinity Kappa XLT

The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis.

The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.

Kappa XLT receives EEG signals when connected to an Infinity EEG pod.

The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.

The SCIO module sample breathing gases from adults and pediatrics. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to Kappa XLT.

With etCO2 the Kappa XLT can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The device can interface with specific third party devices via an RS 232 connection.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations.

### MRI Compatibility Statement:

The Infinity Kappa XLT is not compatible for use in a MRI magnetic field.

Prescription Use - -Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumuma